Official announcements
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Replacement
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Medicines
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28/06/2011
The marketing authorization holder informed its supplied customers in a letter dated June 28, 2011, that due to a minor deviation (falling below the specification limit) in the active ingredient activity of papain, the affected batch is being…
Replacement
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Medicines
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28/06/2011
The marketing authorization holder informed its supplied customers in a letter dated June 28, 2011, that due to a minor deviation (falling below the specification limit) in the active ingredient activity of bromelain, the affected batch is being…
Replacement
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Medicines
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06/06/2011
The marketing authorization holder informed its supplied customers by letter dated 06.06.2011 that a precautionary recall is being carried out due to three reports of crystallization of the calcium solution.
Replacement
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Medicines
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30/05/2011
The marketing authorization holder informed its supplied customers in a letter dated May 26, 2011, that the degradation product prostaglandin A1 (PGA1) was above the specified limit at the end of the 24-month period and thus a replacement had to be…
Recall
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Medicines
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26/05/2011
The marketing authorization holder informed its supplied customers in a letter dated May 20, 2011, that the content of available iodine in the three batches listed above may fall slightly below the specification limit before expiry of the shelf life…
Replacement
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Medicines
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11/05/2011
The marketing authorization holder informed its supplied customers in a letter dated May 11, 2011, that due to reports of an unpleasant, moldy odor, the affected batches must be recalled. This odor emanates from the primary packaging (plastic…
Replacement
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Medicines
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05/05/2011
The marketing authorization holder informed its supplied customers by letter dated May 3, 2011, that an atypically elevated value of a known, characterized degradation product was detected in the batches listed above. However, the values are within…
Medicines
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05/05/2011
Decree concerning "Standards for the preparation for use, application and disposal of cytostatic drugs" (acc. to § 2 Z 12 GQG). See related files.
Replacement
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Medicines
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29/04/2011
In a letter dated April 29, 2011, the marketing authorization holder informed its customers that the two batches had to be exchanged because routine stability tests had revealed that the test values for active ingredient release and disintegrability…
Replacement
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Medicines
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28/04/2011
The marketing authorization holder has informed its supplied customers by letter dated April 28, 2011, that a small piece of glass has been detected in a vial of the above mentioned batch. As a precaution, Mallinckrodt/Covidien (NL) is recalling the…